AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Condition(s) studied
Investigational drug(s) / intervention(s)
Heparin: Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient. Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.
Study summary
This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).
Eligibility
Primary outcome measure(s)
- Ordinal endpoint reflecting survival — 30 days
Survival to hospital discharge without ICU-level organ support. Organ support is defined as receipt of high flow nasal oxygen, invasive or non-invasive mechanical ventilation, vasopressor/inotropic therapy, or extracorporeal life support (ECLS) within an ICU. This outcome reflects disease progression to ICU-level organ failure or the worst possible outcome (death). It was chosen because of its importance to patients, clinicians, and other stakeholders. Given the limited number of ICU beds, reducing the burden of critical illness has important health system capacity implications.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Chicago | Chicago | Illinois | Recruiting |
| Ochsner Clinic | Jefferson | Louisiana | Recruiting |
| Maine Medical Centre | Portland | Maine | Recruiting |
| Henry Ford Health System | Dearborn | Michigan | Completed |
| Cooper University Health Care | Camden | New Jersey | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Hospital Estadual Dr. Jayme Santos Neves | Serra | Espírito Santo | Recruiting |
| Hospital Evangelico de Vila Velha | Vila Velha | Espírito Santo | Recruiting |
| Santa Casa de Misericordia de Itabuna | Itabuna | Estado de Bahia | Completed |
| Hospital Brasilia | Brasília | Federal District | Completed |
| Instituto de Cardiologia e Transplantes do Distrito Federal | Brasília | Federal District | Completed |
| Hospital de Messejana Dr. Carlos Alberto Studart Gomes | Goiânia | Goiás | Recruiting |
| Hospital Ruy Azeredo | Goiânia | Goiás | Recruiting |
| Instituto Goiano de Oncologia e Hematologia - INGOH | Goiânia | Goiás | Recruiting |
| Hospital São Julião | Campo Grande | Mato Grosso do Sul | Recruiting |
| Santa Casa de Campo Grande | Campo Grande | Mato Grosso do Sul | Recruiting |
| Hospital Felicio Rocho | Belo Horizonte | Minas Gerais | Completed |
| NUPEC-Orizonti | Belo Horizonte | Minas Gerais | Completed |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Minas Gerais | Recruiting |
| Hospital das Clínicas da Universidade Federal do Triângulo Mineiro | Uberaba | Minas Gerais | Recruiting |
| Hospital do Rocio | Campo Largo | Paraná | Recruiting |
| Hospital Santa Cruz | Curitiba | Paraná | Recruiting |
| PUCPR | Curitiba | Paraná | Completed |
| Hospital Clementino Fraga Filho - UFRJ | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Hospital Bruno Born | Lajeado | Rio Grande do Sul | Recruiting |
| Hospital Sao Vicente de Paulo | Passo Fundo | Rio Grande do Sul | Recruiting |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital Universitario de Santa Maria | Santa Maria | Rio Grande do Sul | Completed |
| Hospital Sao Jose | Criciúma | Santa Catarina | Recruiting |
| Hospital Regional Homero Miranda Gomes | São José | South Carolina | Completed |
| UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu | Botucatu | São Paulo | Recruiting |
| Hospital Universitario Sao Francisco na Providencia na Deus | Bragança Paulista | São Paulo | Recruiting |
| Fundação Centro Médico de Campinas | Campinas | São Paulo | Recruiting |
| IPECC | Campinas | São Paulo | Recruiting |
| CiTen - Centro Hospital Municipal Antonio Giglio | Osasco | São Paulo | Recruiting |
| Hospital Regional de Presidente Prudente | Presidente Prudente | São Paulo | Recruiting |
| Hospital Estadual de Serrana | Ribeirão Preto | São Paulo | Not Yet Recruiting |
| Hospital Nipo-Brasileiro | São Paulo | São Paulo | Recruiting |
| HCFMUSP | São Paulo | São Paulo | Recruiting |
| Santa Casa de Misericordia de Sao Paulo | São Paulo | São Paulo | Completed |
+ 28 more sites — see the full list on the official registry below.
More University of Manitoba trials in Canada
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05848713 on ClinicalTrials.gov ↗ ← All trials in Canada